To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of oral 882C87 in immunocompromised patients.

Condition	Treatment or Intervention	Phase
HIV Infections Chickenpox	Drug: Netivudine  Drug: Acyclovir	Phase III

Further Study Details: 

Expected Total Enrollment:  400

Patients are randomized to receive either 882C87 or acyclovir with corresponding placebos for 14 days, with two hundred patients in each of the two groups. They are stratified by presence or absence of HIV infection. Patients undergo 6 months of follow-up.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• Acute localized herpes zoster or rash present less than 72 hours, verified by clinical diagnosis.
• Immunocompromised condition primarily as a result of documented HIV infection, malignancy, chemotherapy or radiation therapy, solid organ or bone marrow transplant, or chronic immunosuppressive therapy.
• Life expectancy of at least 6 months.
• Ability to cooperate with the requirements of the study.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Evidence of cutaneous or visceral dissemination (more than 20 discrete lesions outside adjacent dermatomes).
• Acute, life-threatening condition.
• Significant malabsorption syndrome or other gastrointestinal dysfunction that may severely reduce drug absorption.
• Intolerance of oral medication. Concurrent Medication: Excluded:
• Tricyclic antidepressants or anti-epileptics.
• Topical applications to the zoster lesions that would obscure evaluation.
• Fluorouracil and flucytosine.
• Systemic therapy with agents with antiherpetic activity (from 2 weeks prior to first dose to day 28 of study).
• Probenecid or other drugs likely to affect elimination of study drugs (from 2 days prior to first dose to day 14 of the study).
• Capsaicin (Zostrix).
• Warfarin (Coumadin) during 14 days of treatment. Patients with the following prior conditions are excluded: History of intolerance, hypersensitivity, or severe drug reaction to acyclovir. Prior Medication: Excluded:
• Systemic therapy with agents with antiherpetic activity (including interferon) within the past 2 weeks.
• Probenecid or other drugs likely to affect the elimination of 882C87 or acyclovir within the past 48 hours.
• Drugs likely to interact with 882C87 (e.g., fluorouracil or flucytosine) within the past 7 days.
• Zoster immune globulin or zoster immune plasma within the previous month. History of alcohol or drug abuse within the previous 6 months or current methadone therapy.

Alabama
      SORRA / NC Research Ctr, Birmingham,  Alabama,  35234,  United States
      Simon - Williamson Clinic, Birmingham,  Alabama,  35211,  United States
Arizona
      Univ of Arizona / Univ Med Ctr, Tucson,  Arizona,  85724,  United States
California
      AIDS Community Research Consortium, Redwood City,  California,  94063,  United States
      Cedars Sinai Med Ctr, Los Angeles,  California,  90048,  United States
      Saint Francis Mem Hosp, San Francisco,  California,  94109,  United States
      Sunnyvale Med Clinic, Sunnyvale,  California,  94086,  United States
Connecticut
      Clinical Research Consultants, Trumbull,  Connecticut,  06611,  United States
Iowa
      Med Associates Clinic, Dubuque,  Iowa,  52001,  United States
Louisiana
      Oschner Clinic, New Orleans,  Louisiana,  70121,  United States
Missouri
      Washington Univ, St. Louis,  Missouri,  63110,  United States
New Mexico
      New Mexico Med Group, Albuquerque,  New Mexico,  87110,  United States
North Carolina
      Jordon Diagnostics and Research Inc, High Point,  North Carolina,  27262,  United States
      Hanover Med Specialists, Wilmington,  North Carolina,  28401,  United States
Oregon
      Oregon Health Sciences Univ, Portland,  Oregon,  97201,  United States
      Oregon Research Group, Eugene,  Oregon,  97401,  United States
Rhode Island
      Roger Williams Med Ctr, Providence,  Rhode Island,  02908,  United States
      Silver Lake Med Inc, Providence,  Rhode Island,  02909,  United States
Tennessee
      Vanderbilt Med Ctr, Nashville,  Tennessee,  37232,  United States
Texas
      N Texas Ctr for AIDS & Clin Rsch, Dallas,  Texas,  75219,  United States
      MacGregor Med Association, Houston,  Texas,  77054,  United States
      Univ TX Med Branch, Nassau Bay,  Texas,  77058,  United States
Washington
      Infections Ltd / Physicians Med Ctr, Tacoma,  Washington,  98405,  United States
Wisconsin
      Rhinelander Med Ctr, Rhinelander,  Wisconsin,  54501,  United States
      Med Consultants LTD, Milwaukee,  Wisconsin,  53215,  United States

Study ID Numbers:  130A
Record last reviewed:  May 1994
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002315
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08